Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NNC0487-0111 · 17 trials · 8 indications
Measured as percentage of body weight.
Measured in days.
Measured in days.
Measured as events/hour.
WOMAC is a participant reported outcome (PRO) measures symptoms in the areas of pain, stiffness, and physical function in participants with osteoarthritis of the hip and/or knee. The measure consists of 24 items yielding 3 subscale scores and 1 total score. WOMAC raw scores are transformed to a standardised 0 to 100 score range. Higher scores indicate worse pain, stiffness, physical function, and overall osteoarthritis-related disability. Subscale score for pain ranges 0-100, where higher score indicates worse pain. Measured as score on a scale.
Measured as score on a scale. Western Ontario and McMaster Universities Arthritis Index (WOMAC) measures symptoms in the areas of pain, stiffness, and physical function. The measure consists of 24 items yielding 3 subscale scores and 1 total score. WOMAC raw scores are transformed to a standardised 0 to 100 score range. Higher scores indicate worse pain, stiffness, physical function, and overall osteoarthritis- related disability.
Number of events
Number of events
Measured as hours\*nanomole per liter (nmol\*h/L)
Measured as milligram per minute per kilogram (mg/min/kg)
Measured as percentage change of energy.
Measured as percentage change of energy.
Measured as percentage change of energy.
Number of events
Measured as hours\*nanomole per liter (h\*nmol/L).
Measured as hours\*nanomoles per liter (h\*nmol/L)
Number of events
| Arm | Type | Description |
|---|---|---|
| NNC0487-0111 | EXPERIMENTAL | Participants will receive NNC0487-0111 and placebo matched to semaglutide subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
| Semaglutide | ACTIVE_COMPARATOR | Participants will receive semaglutide and placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matched to NNC0487-011 s.c. once weekly. |
| NNC0487-0111 dose level 1 | EXPERIMENTAL | Participants will be randomized to receive NNC0487-0111 dose level 1 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
| NNC0487-0111 dose level 2 | EXPERIMENTAL | Participants will be randomized to receive NNC0487-0111 dose level 2 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
| NNC0487-0111 dose level 3 | EXPERIMENTAL | Participants will be randomized to receive NNC0487-0111 dose level 3 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
| NNC0487-0111 dose level 4 | EXPERIMENTAL | Participants will be randomized to receive NNC0487-0111 dose level 4 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
| Severe hepatic impairment | EXPERIMENTAL | Participants will receive single dose of NNC0487-0111 subcutaneously. |
| Moderate hepatic impairment | EXPERIMENTAL | Participants will receive single dose of NNC0487-0111 subcutaneously. |
| Mild hepatic impairment | EXPERIMENTAL | Participants will receive single dose of NNC0487-0111 subcutaneously. |
| Normal hepatic impairment | EXPERIMENTAL | Participants will receive single dose of NNC0487-0111 subcutaneously. |
| NNC0487-0111 (dose 1) | EXPERIMENTAL | Participants will be randomized to receive a single dose of NNC0487-0111. |
| NNC0487-0111 (dose 2) | EXPERIMENTAL | Participants will be randomized to receive a single dose of NNC0487-0111. |
| NNC0487-0111 (dose 3) | EXPERIMENTAL | Participants will be randomized to receive a single dose of NNC0487-0111. |
| Mild Renal Impairment | EXPERIMENTAL | Participants with mild renal impairment (estimated glomerular filtration rate \[eGFR\] - 60 - 89 milliliter per min \[mL/min\]) will administer a single dose of NNC0487-0111 on Day 1. |
| Moderate Renal Impairment | EXPERIMENTAL | Participants with moderate renal impairment (eGFR - 30 - 59 mL/min) will administer a single dose of NNC0487-0111 on Day 1. |
| Severe Renal Impairment | EXPERIMENTAL | Participants with severe renal impairment (eGFR - less than 30 mL/min not requiring dialysis) will administer a single dose of NNC0487-0111 on Day 1. |
| End-Stage Renal Disease (ESRD) | EXPERIMENTAL | Participants with ESRD (requiring dialysis treatment) will administer a single dose of NNC0487-0111 on Day 1. |
| Normal Renal Function | EXPERIMENTAL | Participants with normal renal function (eGFR - greater than or equals 90) will administer a single dose of NNC0487-0111 on Day 1. |
| Phase A: NNC0487-0111 (formulation D) | EXPERIMENTAL | Participants will receive once daily dose of six different dose levels (1-6) of NNC0487-0111 (formulation D) at increasing doses (the dose will be escalated every 3 weeks). |
| Phase A: NNC0487-0111 (formulation C) | ACTIVE_COMPARATOR | Participants will receive once daily dose of six different dose levels (1-6) of NNC0487-0111 (formulation C) at increasing doses (the dose will be escalated every 3 weeks). |
| Phase B: NNC0487-0111 (formulation D) | EXPERIMENTAL | Participants will receive once daily dose of dose level 6 of NNC0487-0111 (formulation D). |
| Phase B: NNC0487-0111 (formulation C) | ACTIVE_COMPARATOR | Participants will receive once daily dose of dose level 6 of NNC0487-0111 (formulation C). |
| Name | Type | Description |
|---|---|---|
| NNC0487-0111 | DRUG | NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. |
| Semaglutide | DRUG | Semaglutide will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. |
| Placebo (matched to NNC0487-0111) | DRUG | Placebo matched to NNC0487-0111 will be administered subcutaneously using pre- filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. |
| Placebo (matched to semaglutide) | DRUG | Placebo matched to semaglutide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. |
| Placebo | DRUG | Placebo (matched to NNC0487-011) will be administered subcutaneously. |
| Placebo (matched to NNC0487-0111 ) | DRUG | Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. |
| Placebo (NNC0487-0111) | DRUG | Placebo matching NNC0487-0111 will be administered as a subcutaneous (s.c. under the skin) injection. |
| NNC0487-0111 (formulation D) | DRUG | Participants will receive NNC0487-0111 (formulation D) tablet once daily. |
| NNC0487-0111 (formulation C) | DRUG | Participants will receive NNC0487-0111 (formulation C) tablet once daily. |
Key Inclusion Criteria: * Male or female (sex at birth). * Age 18 years or above at the time of signing informed consent. * Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening. * Haemoglobin A1c (HbA1c) 7-10 percentage (%) (53-86 millimole per mole \[mmol/mol\]) (both inclusive) as ...
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NNC0487-0111 is an investigational small molecule being developed by Novo Nordisk for the treatment of diabetes mellitus, overweight, obesity, and type 2 diabetes. It is currently in Phase 3 clinical development and is being studied in both oral tablet and injectable formulations.
NNC0487-0111 is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker symbol NVO. The company is conducting clinical trials to evaluate the drug's safety and efficacy in metabolic conditions.
NNC0487-0111 is currently in Phase 3 clinical development. It has completed Phase 1 and Phase 2 trials and is now being evaluated in a Phase 3 study called AMAZE 8, which compares the drug to semaglutide in people with excess body weight and type 2 diabetes.
NNC0487-0111 has been studied in several clinical trials, including NCT06049329, NCT06064006, NCT06478563, and NCT07400107. The Phase 3 trial NCT07400107, known as AMAZE 8, is not yet recruiting and will enroll 1000 participants across multiple countries.
Yes, NNC0487-0111 is also known as Amycretin. In clinical trials, the drug has been referred to by both names, with some studies using the name Amycretin in their titles while others use the code name NNC0487-0111.